Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects

Swine-Origin Influenza A H1N1 Virus Clinical Trial

Official title:

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000207
• Other study ID #: V110_08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 21, 2009
• Last updated: November 30, 2016
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.

Description:

This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were randomized at a 1:1 ratio to receive either 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59) or 7.5μg of cell-derived H1N1sw vaccine formulated with full MF59 (7.5_fullMF59). Subjects were not informed of their allocated doses. Two vaccinations were administered IM three weeks apart. Subjects in both the vaccine groups were stratified into three age strata: 6 to 35 months, 3 to 8 years and 9 to 19 years. Blood samples were collected at day 1 (baseline), three weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e., day 1 to day 7 and day 22 to day 28). All adverse events (AE), serious adverse events (SAE), and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 19 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese aged 6 months to 19 years

Exclusion Criteria:

• History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients

• Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start

• Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week

• History of progressive or severe neurological disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Swine-Origin Influenza A H1N1 Virus

Intervention

Biological:
• Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines

Locations

Country	Name	City	State
Japan	Sites 1,2,3,4,5	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Sawata H, Nakura N, Jaeger RK, Lattanzi M. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Adv Ther. 2010 Jul;27(7):444-57. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6		6 weeks	Yes
Secondary	AEs, vital signs, laboratory tests		6 weeks	Yes

External Links

•   Results for V110_08 from the Novartis Clinical Trials website